The World Health Organization (WHO) has published the Good Regulatory Practices (GRP) and Good Reliance Practices (GRelP) that will be critical for countries’ regulatory system strengthening cooperation, convergence and transparency to leverage resources more efficiently and ensure that quality health products reach people faster.
The globalization of markets, the sophistication of health technologies, the rapid evolution of regulatory science and the increasing complexity of supply chains have shown regulators the importance of international cooperation in ensuring the safety, quality, efficacy or performance of locally used products.
The GRelP, is aimed to promote a more efficient approach to regulation, thereby improving and expediting access to quality-assured, effective and safe medical products.
GRelP includes the overarching principles of “regulatory reliance” in the field of regulation of medical products, addressing all the regulatory functions in the life cycle of these products. WHO defines regulatory reliance as “The act whereby the regulatory authority in one jurisdiction may take into account and give significant weight to evaluations performed by another regulatory authority or trusted institution in reaching its own decision”.
The other document, GRP provides regulators with advice on how to establish and implement sound, affordable, efficient regulation of medical products as an important part of health system performance and sustainability. WHO presents nine principles in this document: legality, consistency, independence, impartiality, proportionality, flexibility, clarity, efficiency and transparency, that are relevant to all regulatory authorities, irrespective of their resources, sophistication or regulatory model.
You can find both documents as annexes 10 and 11 in the 55th report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP).